Assessing Facilitator Fidelity to Principles of Public Deliberation: Tutorial.

Public deliberation, or deliberative democracy, is a method used to elicit informed perspectives and justifiable solutions to ethically fraught or contentious issues that affect multiple stakeholder groups with conflicting interests. Deliberative events bring together stakeholders (deliberants) who are provided with empirical evidence on the central issue or concern and then asked to discuss the evidence, consider the issue from a societal perspective, and collectively work toward a justifiable resolution. There is increasing interest in this method, which warrants clear guidance for evaluating the quality of its use in research. Most of the existing literature on measuring deliberation quality emphasizes the quality of deliberants' inputs (eg, engagement and evidence of compromise) during deliberative sessions. Fewer researchers have framed quality in terms of facilitator inputs, and these researchers tend to examine inputs that are consistent with generic group processes. The theory, process, and purpose of public deliberation, however, are distinct from those of focus groups or other group-based discussions and warrant a mechanism for measuring quality in terms of facilitator fidelity to the principles and processes of deliberative democracy. In our public deliberation on ethical conflicts in minor consent for biomedical HIV prevention research, we assessed facilitator fidelity to these principles and processes because we believe that such assessments serve as a component of a comprehensive evaluation of overall deliberation quality. We examined verbatim facilitator remarks in the deliberation transcripts and determined whether they aligned with the 6 principles of public deliberation: equal participation, respect for the opinions of others, adoption of a societal perspective, reasoned justification of ideas, expression of diverse opinions, and compromise or movement toward consensus. In this tutorial, we describe the development of a blueprint to guide researchers in assessing facilitator fidelity, share 3 templates that will assist them in the task, and describe the results of our assessment of facilitator fidelity in 1 of the 4 sites in which we conducted deliberations.

Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents' Willingness to Participate.

PURPOSE: Minor adolescents are often excluded from HIV prevention clinical trials due to unresolved ethical issues. Their under-representation in research leads to delayed access to new HIV prevention approaches. We examine the relationship between consent procedures, trial features, demographic and social characteristics, and minor adolescents' willingness to participate (WTP) in biomedical HIV prevention research. METHODS: We recruited 14-17-year-olds at risk of HIV for this quasi-experimental study. Adolescents were randomly assigned to (1) self-consent, (2) adult permission required, or (3) parental permission required and underwent simulated consent procedures for two types of HIV prevention trials. They rated likelihood of participating in each study if offered the opportunity and completed a survey with demographic, social, and behavioral measures. RESULTS: One hundred and twenty nine adolescents with diverse identities and socioeconomic status enrolled. Among the 58% of participants who identified as lesbian, gay, bisexual, transgender, or queer (LGBTQ), 76% were out to at least one parent/guardian (outness). Mean WTP was 3.6 (of 5; 5 = definitely would participate) across all participants and both trial types. We found no evidence of an association between WTP and consent condition, LGBTQ identity, or outness. However, medical mistrust, communication with parents, and concern about HIV were associated with WTP. DISCUSSION: Our results suggest adolescents are willing to participate in HIV prevention trials and parental involvement in the consent process may not be the most important deciding factor. However, variation in WTP within consent groups, and variation in other significant variables, underscores the need for individualized approaches to recruitment and consent for these trials.

Ethical Approaches to Vaccine Allocation and Administration in Carceral Settings, With a Focus on Youth.

COVID-19 has disproportionately impacted Americans in carceral settings and secure facilities. A disproportionate number of persons who are confined to carceral settings and secure facilities are members of racial, ethnic, and socioeconomic groups who experience a significant burden of COVID-19 morbidity and mortality. The pandemic-related disparities experienced by minoritized and detained adult populations have received national attention, but the burden of COVID-19 risk among justice-involved youth has been largely absent from these national conversations. With more than 40,000 youth in carceral settings, their COVID-19 risks and prevention needs warrant specific consideration, especially as vaccine distribution programs expand. Youth have been assigned a lower priority status in most state vaccine allocation plans, but youth in carceral settings are at increased risk compared with their peers, raising important questions about how to ethically allocate and administer vaccines to them. In this article we examine ethical issues that arise in the health care of minors in carceral settings and identify an ethical model that could be used to reconsider the allocation of COVID-19 vaccines.

Synthesizing Adaptive Digital Bioethics to Guide the Use of Interactive Communication Technologies in Adolescent Behavioral Medicine: A Systematic Configurative Review.

Despite the continuing integration of digital outreach tools into adolescent preventive services, adaptive guidance for their ethical use remains limited. In this configurative review, we synthesize the ad hoc, applied digital bioethics developed in adolescent human immunodeficiency virus prevention science. By focusing on generalizable technological affordances, while balancing privacy and autonomy, we offer strategies for identifying potential technologically mediated harms that can transcend specific platforms, tools, or the knowledge levels of individual clinicians. Clinical vignettes illustrate the application of these strategies.

Undergraduate nursing students' COVID-19 vaccine intentions: A national survey.

INTRODUCTION: In December 2020, the first two COVID-19 vaccines were approved in the United States (U.S.) and recommended for distribution to front-line personnel, including nurses. Nursing students are being prepared to fill critical gaps in the health care workforce and have played important supportive roles during the current pandemic. Research has focused on vaccine intentions of current health care providers and less is known about students' intentions to vaccinate for COVID-19. METHODS: A national sample of undergraduate nursing students were recruited across five nursing schools in five U.S. regions in December 2020. The survey measured perceived risk/threat of COVID-19, COVID-19 vaccine attitudes, perceived safety and efficacy of COVID-19 vaccines, sources for vaccine information and level of intention to become vaccinated [primary, secondary (i.e., delayed), or no intention to vaccinate]. RESULTS: The final sample consisted of 772 students. The majority (83.6%) had intentions to be vaccinated, however of those 31.1% indicated secondary intention, a delay in intention or increased hesitancy). The strongest predictors of primary intention were positive attitudes (OR = 6.86; CI = 4.39-10.72), having lower safety concerns (OR = 0.26; CI = 0.18-0.36), and consulting social media as a source of information (OR = 1.56; CI = 1.23-1.97). Asian (OR = 0.47; CI = 0.23-0.97) and Black (OR 0.26; CI = 0.08-0.80) students were more likely to indicate secondary intention as compared to primary intention. Students in the Midwest were most likely to indicate no intention as compared to secondary intention (OR = 4.6; CI = 1.32-16.11). CONCLUSIONS: As the first two COVID-19 vaccines were approved/recommended in the U.S. nursing students had overall high intentions to vaccinate. Findings can guide development of educational interventions that reduce concerns of vaccine safety that are delivered in a way that is supportive and affirming to minoritized populations while being respectful of geo-political differences.

A Review of Nursing Position Statements on Racism Following the Murder of George Floyd and Other Black Americans.

ABSTRACT: National outrage over the killings of George Floyd and other Black Americans in the United States prompted public outcry against police brutality and racism in law enforcement and drew national attention to systemic racism as a public health crisis. In response, during the summer of 2020 many health organizations issued position statements in response to the murders. This article examines such statements issued by 3 prominent nursing organizations and 18 schools of nursing. Thematic analysis revealed six themes in the statements of the professional organizations, and a content analysis revealed that the statements of the schools of nursing were generally aligned with these themes. Such position statements can provide a viable approach to the public commitment to anti-racist reforms, but it is unclear if such statements can promote meaningful and measurable change.

Undergraduate nursing students' perceptions on nursing education during the 2020 COVID-19 pandemic: A national sample.

BACKGROUND: In 2020, nursing educational programs were abruptly interrupted and largely moved online due to the COVID-19 pandemic. PURPOSE: To explore nursing students' perspectives about the effects of the pandemic on their education and intention to join the nursing workforce. METHODS: Undergraduate nursing students from 5 universities across 5 United States regions were invited to participate in an online survey to elicit both quantitative and qualitative data. FINDINGS: The final sample included quantitative data on 772 students and qualitative data on 540 students. Largely (65.1%), students reported that the pandemic strengthened their desire to become a nurse; only 11% had considered withdrawing from school. Qualitatively, students described the effect of the pandemic on their psychosocial wellbeing, adjustment to online learning, and challenges to clinical experiences. CONCLUSION: Findings highlighted the need to develop emergency education preparedness plans that address student wellbeing and novel collaborative partnerships between schools and clinical partners.

Measuring research mistrust in adolescents and adults: Validity and reliability of an adapted version of the Group-Based Medical Mistrust Scale.

Mistrust of health care providers among persons of color is a significant barrier to engaging them in research studies. Underrepresentation of persons of color is particularly problematic when the health problem under study disproportionately affects minoritized communities. The purpose of this study was to test the validity and reliability of an abbreviated and adapted version of the Group Based Medical Mistrust Scale. The GBMMS is a 12-item scale with three subscales that assess suspicion, experiences of discrimination, and lack of support in the health care setting. To adapt for use in the research setting, we shortened the scale to six items, and replaced "health care workers" and "health care" with "medical researchers" and "medical research," respectively. Using panelists from a market research firm, we recruited and enrolled a racially and ethnically diverse sample of American adults (N = 365) and adolescents aged 14-17 (N = 250). We administered the adapted scale in a web-based survey. We used Cronbach's alpha to evaluate measure internal reliability of the scale and external factor analysis to evaluate the relationships between the revised scale items. Five of the six items loaded onto a single factor, with (α = 0.917) for adolescents and (α = 0.912) for adults. Mean scores for each item ranged from 2.5-2.9, and the mean summary score (range 6-25) was 13.3 for adults and 13.1 for adolescents. Among adults, Black respondents had significantly higher mean summary scores compared to whites and those in other racia/ethnic groups (p<0.001). There was a trend toward significance for Black adolescents as compared to white respondents and those in other racial/ethnic groups (p = 0.09). This five-item modified version of the GBMMS is reliable and valid for measuring research mistrust with American adults and adolescents of diverse racial and ethnic identities.

Innovative Approaches to Obtain Minors' Consent for Biomedical HIV Prevention Trials: Multi-Site Quasi-Experimental Study of Adolescent and Parent Perspectives.

BACKGROUND: Despite the high burden of new HIV infections in minor adolescents, they are often excluded from biomedical HIV prevention trials, largely owing to the ethical complexities of obtaining consent for enrollment. Researchers and ethics regulators have a duty to protect adolescents-as a special category of human subjects, they must have protection that extends beyond those afforded to all human subjects. Typically, additional protection includes parental consent for enrollment. However, parental consent can present a risk of harm for minor adolescents. Research involving minor adolescents indicate that they are unwilling to join biomedical trials for stigmatized health problems, such as HIV, when parental consent is required. This presents a significant barrier to progress in adolescent HIV prevention by creating delays in research and the translation of new scientific evidence generated in biomedical trials in adult populations. OBJECTIVE: This protocol aims to examine how parental involvement in the consent process affects the acceptability of hypothetical participation in biomedical HIV prevention trials from the perspectives of minor adolescents and parents of minor adolescents. METHODS: In this protocol, we use a quasi-experimental design that involves a simulated consent process for 2 different HIV prevention trials. The first trial is modeled after an open-label study of the use of tenofovir disoproxil fumarate and emtricitabine as preexposure prophylaxis for HIV. The second trial is modeled after a phase IIa trial of an injectable HIV integrase inhibitor. There are 2 groups in the study-minor adolescents aged 14 to 17 years, inclusive, and parents of minor adolescents in the same age range. The adolescent participants are randomized to 1 of 3 consent conditions with varying degrees of parental involvement. After undergoing a simulated consent process, they rate their willingness to participate (WTP) in each of the 2 trials if offered the opportunity. The primary outcome is WTP, given the consent condition. Parents undergo a similar process but are asked to rate the acceptability of each of the 3 consent conditions. The primary outcome is acceptability of the consent method for enrollment. The secondary outcomes include the following: capacity to consent among both participant groups, the prevalence of medical mistrust, and the effects of the study phase (eg, phase IIa vs the open-label study) and drug administration route (eg, oral vs injection) on WTP (adolescents) and acceptability (parents) of the consent method. RESULTS: Enrollment began in April 2018 and ended mid-September 2019. Data are being analyzed and dissemination is expected in April 2020. CONCLUSIONS: The study will provide the needed empirical data about minor adolescents' and parents' perspectives on consent methods for minors. The evidence generated can be used to guide investigators and ethics regulators in the design of consent processes for biomedical HIV prevention trials. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16509.

Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV.

PURPOSE: There is a persistent HIV epidemic among sexual and gender minority adolescents in the U.S. Oral pre-exposure prophylaxis (PrEP) is an efficacious prevention strategy, but not yet approved for minors. Minors' access to biomedical HIV prevention technologies is impeded by the ethical and legal complexities of consent to research participation. We explore autonomous consent and study experiences among minor and adult participants in Project PrEPare, a Phase II safety study of PrEP for HIV prevention. METHODS: Data for this mixed-methods descriptive study were collected via self-administered web-survey and in-depth telephone interviews in early 2016. Eligible participants were previously enrolled in Project PrEPare. We attempted to contact 191 participants; 74 were reached and expressed interest in participating and 58 enrolled. RESULTS: Participants nearly universally felt well informed, understood the study, and freely volunteered with the clear understanding they could withdraw any time. All felt supported by study staff, but a small minority wished for more support during enrollment. Minors were more likely than adults to indicate a wish for more support in decision-making, and adults expressed higher satisfaction with their decision compared to minors. There was no association between elements of consent and Project PrEPare study outcomes. CONCLUSIONS: Participants had an overwhelmingly positive experience in a Phase II safety study of PrEP for HIV prevention. Some minors wished for more support during the decision-making process, but none consulted their parents about the decision. Our results support the inclusion of decisional supports in consent processes for adolescents, while also protecting their privacy.

Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents.

BACKGROUND: Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. METHODS: We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. RESULTS: Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties-protective and scientific-previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. CONCLUSIONS: Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.

Sexual learning among East African adolescents in the context of generalized HIV epidemics: A systematic qualitative meta-synthesis.

BACKGROUND: AIDS-related illness is the leading cause of mortality for adolescents in sub-Saharan Africa. Together, Kenya, Tanzania, and Uganda account for 21% of HIV-infected adolescents in sub-Saharan Africa. The United Nations framework for addressing the epidemic among adolescents calls for comprehensive sexual and reproductive health education. These HIV prevention efforts could be informed by a synthesis of existing research about the formal and informal sexual education of adolescents in countries experiencing generalized epidemics. The purpose of this study was to describe the process of sexual learning among East African adolescents living in the context of generalized HIV epidemics. METHODS: Qualitative metasynthesis, a systematic procedure for integrating the results of multiple qualitative studies addressing a similar phenomenon, was used. Thirty-two research reports met study inclusion criteria. The reports were assessed in a four-step analytic process: appraisal, classification of findings, synthesis of findings, and construction of a framework depicting the process of sexual learning in this population. RESULTS: The framework includes three phases of sexual learning: 1) being primed for sex, 2) making sense of sex, and 3) having sexual experiences. Adolescents were primed for sex through gender norms, cultural practices, and economic structures as well as through conversations and formal instruction. They made sense of sex by acquiring information about sexual intercourse, reproduction and pregnancy, sexually transmitted infections, and relationships and by developing a variety of beliefs and attitudes about these topics. Some adolescents described having sexual experiences that met wants or needs, but many experienced sex that was coerced or violent. Whether sex was wanted, coerced, or violent, adolescents experienced worry about sexually transmitted infections or premarital pregnancy. CONCLUSIONS: The three phases of sexual learning interact to shape adolescents' sexual lives and their risk for HIV infection. This framework will contribute to the development of sexual education programs that address HIV risk within the broader context of sexual learning.

Word Adjacency Graph Modeling: Separating Signal From Noise in Big Data.

There is a need to develop methods to analyze Big Data to inform patient-centered interventions for better health outcomes. The purpose of this study was to develop and test a method to explore Big Data to describe salient health concerns of people with epilepsy. Specifically, we used Word Adjacency Graph modeling to explore a data set containing 1.9 billion anonymous text queries submitted to the ChaCha question and answer service to (a) detect clusters of epilepsy-related topics, and (b) visualize the range of epilepsy-related topics and their mutual proximity to uncover the breadth and depth of particular topics and groups of users. Applied to a large, complex data set, this method successfully identified clusters of epilepsy-related topics while allowing for separation of potentially non-relevant topics. The method can be used to identify patient-driven research questions from large social media data sets and results can inform the development of patient-centered interventions.

Finding the Patient's Voice Using Big Data: Analysis of Users' Health-Related Concerns in the ChaCha Question-and-Answer Service (2009-2012).

BACKGROUND: The development of effective health care and public health interventions requires a comprehensive understanding of the perceptions, concerns, and stated needs of health care consumers and the public at large. Big datasets from social media and question-and-answer services provide insight into the public's health concerns and priorities without the financial, temporal, and spatial encumbrances of more traditional community-engagement methods and may prove a useful starting point for public-engagement health research (infodemiology). OBJECTIVE: The objective of our study was to describe user characteristics and health-related queries of the ChaCha question-and-answer platform, and discuss how these data may be used to better understand the perceptions, concerns, and stated needs of health care consumers and the public at large. METHODS: We conducted a retrospective automated textual analysis of anonymous user-generated queries submitted to ChaCha between January 2009 and November 2012. A total of 2.004 billion queries were read, of which 3.50% (70,083,796/2,004,243,249) were missing 1 or more data fields, leaving 1.934 billion complete lines of data for these analyses. RESULTS: Males and females submitted roughly equal numbers of health queries, but content differed by sex. Questions from females predominantly focused on pregnancy, menstruation, and vaginal health. Questions from males predominantly focused on body image, drug use, and sexuality. Adolescents aged 12-19 years submitted more queries than any other age group. Their queries were largely centered on sexual and reproductive health, and pregnancy in particular. CONCLUSIONS: The private nature of the ChaCha service provided a perfect environment for maximum frankness among users, especially among adolescents posing sensitive health questions. Adolescents' sexual health queries reveal knowledge gaps with serious, lifelong consequences. The nature of questions to the service provides opportunities for rapid understanding of health concerns and may lead to development of more effective tailored interventions.

Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research.

PURPOSE: The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. METHODS: Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. RESULTS: A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. CONCLUSIONS: The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations.

Reprint of: "This is the medicine:" a Kenyan community responds to a sexual concurrency reduction intervention.

We report the results of the first study designed to evaluate the feasibility and acceptability of an HIV prevention intervention focused on concurrent sexual partnerships. Mathematical models and longitudinal studies of stable couples indicate concurrency plays a critical role in sustaining generalized HIV epidemics in heterosexual populations, and East and Southern African nations identified concurrency reduction as a priority for HIV prevention. "Know Your Network" (KYN) is a single-session community-level concurrency awareness intervention designed to address this need. It is rooted in traditional social network research, but takes advantage of new network methodology and years of participatory action research with communities living in a region of Kenya with the highest HIV prevalence nationally. KYN combines didactic presentation, interactive exercises, high-impact graphics, and a network survey with immediate visualization of the results, to prompt a community conversation about sexual norms. We combined focus group discussions and the traditional east African baraza to evaluate the feasibility and acceptability of KYN for use with adults living in rural Nyanza Province, Kenya. We were able to implement KYN with fidelity to its components. Participants understood the intervention's messages about concurrency and its role in HIV transmission through sexual networks. They agreed to provide anonymous egocentric data on their sexual partnerships, and in return we successfully simulated a representation of their local network for them to view and discuss. This launched a dynamic conversation about concurrency and sexual norms that persisted after the intervention. The concurrency message was novel, but resonant to participants, who reported sharing it with their children, friends, and sexual partners. With clear evidence of KYN's feasibility and acceptability, it would be appropriate to evaluate the effectiveness of the intervention using a community-randomized trial. If effective, KYN would offer an inexpensive complement to ongoing comprehensive HIV prevention efforts in generalized epidemic settings.

"This is the medicine:" A Kenyan community responds to a sexual concurrency reduction intervention.

We report the results of the first study designed to evaluate the feasibility and acceptability of an HIV prevention intervention focused on concurrent sexual partnerships. Mathematical models and longitudinal studies of stable couples indicate concurrency plays a critical role in sustaining generalized HIV epidemics in heterosexual populations, and East and Southern African nations identified concurrency reduction as a priority for HIV prevention. "Know Your Network" (KYN) is a single-session community-level concurrency awareness intervention designed to address this need. It is rooted in traditional social network research, but takes advantage of new network methodology and years of participatory action research with communities living in a region of Kenya with the highest HIV prevalence nationally. KYN combines didactic presentation, interactive exercises, high-impact graphics, and a network survey with immediate visualization of the results, to prompt a community conversation about sexual norms. We combined focus group discussions and the traditional east African baraza to evaluate the feasibility and acceptability of KYN for use with adults living in rural Nyanza Province, Kenya. We were able to implement KYN with fidelity to its components. Participants understood the intervention's messages about concurrency and its role in HIV transmission through sexual networks. They agreed to provide anonymous egocentric data on their sexual partnerships, and in return we successfully simulated a representation of their local network for them to view and discuss. This launched a dynamic conversation about concurrency and sexual norms that persisted after the intervention. The concurrency message was novel, but resonant to participants, who reported sharing it with their children, friends, and sexual partners. With clear evidence of KYN's feasibility and acceptability, it would be appropriate to evaluate the effectiveness of the intervention using a community-randomized trial. If effective, KYN would offer an inexpensive complement to ongoing comprehensive HIV prevention efforts in generalized epidemic settings.